3D Assessment of RV Function in Patients Undergoing LVAD Implantation

Recruiting

• Conditions: Heart Failure

• Registration Number: NCT05376254
• Lead Sponsor: University of Alberta

Brief Summary

This goal of this study is to analyze images of the right ventricle taken via 3D transesophageal echocardiography (TEE) during left ventricular assist device (LVAD) implantation.

Detailed Description

There are two chambers in the heart known as ventricles which are responsible for pumping blood to both the lungs and the rest of the body. The right ventricle pumps blood to the lungs for oxygenation. The left ventricle then delivers this oxygenated blood to the organs in the body. When the left ventricle is damaged enough that it is not able to effectively pump blood then it may be necessary to assist it with a mechanical pump. This pump is called left ventricular assist device (LVAD).

Left ventricular assist devices (LVADs) improve quality of life and survival in patients with end stage heart failure. However, right ventricular (RV) failure is common in 20-50% of LVAD recipients and is associated with perioperative complications.

Traditional two-dimensional ultrasound views of the right ventricle may not accurately depict how well or poorly the right ventricle is working. Three-dimensional (3D) images can overcome the limitations of two-dimensional images and are becoming more commonplace. This goal of this study is to analyze images of the right ventricle taken via 3D transesophageal echocardiography (TEE) during the LVAD implantation to help predict which patients are at higher risk of right ventricular failure within 14 days of the procedure.

Study Timeline

• Study First Submitted: 2022-01-27
• Study Start: 2022-03-22
• Study First Submitted QC: 2022-05-13
• Study First Posted: 2022-05-17
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-17
• Last Update Posted: 2024-05-20
• Primary Completion: 2027-01-19
• Study Completion: 2027-01-19

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Patients will be eligible to be included in the study if they receive either a left-sided:

  1. HeartMate III (Thoratec, Pleasanton, CA)
  2. HeartWare HVAD (HeartWare, Oakville CA)
  3. Levitronix CentriMag (Levitronix LLC, Waltham, MA) LVAD.

Exclusion Criteria

• Patients will be excluded if::

  1. hemodynamic data needed to calculate PAPi or comprehensive echocardiographic images are missing
  2. additional procedures affecting cardiac geometry and/or hemodynamic measurements, such as tricuspid, mitral, and/or aortic valve repair/replacement, were performed at the time of LVAD implantation
  3. sternal closure at the end of the procedure is not possible
  4. RV mechanical support was introduced concurrently with LVAD implantation
  5. inadequate image quality required to obtain a 3D protocol
  6. known contraindication to TEE
  7. unexpected inability to advance probe into the mid-esophagus

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Right ventricular fractional area of change	24 hours	Percentage change in the RV chamber area between end-diastole to end-systole
Right ventricular ejection fraction	24 hours	Amount of blood being pumped out of the right ventricle each time it contracts.
Light ventricular end diastolic volume	24 hours	Amount of blood in the heart's left ventricle just before the heart contracts
Right ventricular free wall strain	24 hours	Prognostic indicator of pulmonary arterial hypertension
Tricuspid annular plane systolic excursion	24 hours	Parameter of global right ventricular function
Right ventricular end diastolic volume	24 hours	Amount of blood in the heart's right ventricle just before the heart contracts
Left ventricular strain	24 hours	Prognostic indicator of hypertensive heart failure
Right ventricular end systolic volume	24 hours	Amount of blood in the heart's right ventricle just after the heart contracts
Left ventricular end systolic volume	24 hours	Amount of blood in the heart's left ventricle just after the heart contracts
Left ventricular ejection fraction	24 hours	Amount of blood being pumped out of the left ventricle each time it contracts.

Secondary Outcome Measures

Name	Time	Method
Bilirubin	14 days	Lab test (\> 2.0 mg/dL)
Body Surface Area	1 day	Demographic measure
Need for right ventricular mechanical support	14 days	Circulatory support
Gender	1 day	Demographic measure
Pulmonary artery pulsatility index	14 days	Hemodynamic index
Aspartate aminotransferase	14 days	Lab test (\> or qual to 80 IU/L)
Central venous pressure	14 days	Pressure in the thoracic vena cava near the right atrium
Age	1 day	Demographic measure
Need for pulmonary vasodilators	14 days	Supportive medication
Need for vasopressors	14 days	Supportive medications
Creatinine	14 days	Lab test (\> or equal to 2.3 mg/dL)

Trial Locations

Locations (1)

Mazankowski Alberta Heart Institute; 🇨🇦 Edmonton, Alberta, Canada